The Role of mTOR (Mammalian Target of Rapamycin) Signaling Pathway in the Antidepressive Effect of Ketamine in Patients with Depressive Disorder.

• Conditions: 1. Men and women at the age between 18 to 65 years, with dextromanual dominance.2. Patients have to answer DSM IV criteria for the major depressive episode, without psychotic symptoms, on the clinical investigation basis, by Mini international neuropsychiatry interview.3. Input score in MADRS Scale higher than 20, what matches medium severity of clinical state in CGI scale higher or equal with 4.4. Mental ability to understand and sign informed consent.; MedDRA version: 14.1Level: PTClassification code 10012378Term: DepressionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2013-000952-17-CZ
• Lead Sponsor: Prague Psychiatric Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-12
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Men and women at the age between 18 to 65 years, with dextromanual dominance, t.j. scores 100 in Edinburgh Handedness Inventory (EHI).
2. Patients have to answer DSM IV criteria for the major depressive episode, without psychotic symptoms, on the clinical investigation basis, by Mini international neuropsychiatry interview (M.I.N.I., Czech version 5.0.0.) - structured interview for psychiatric disorders on axis I based on DSM- IV.
3. Input score in MADRS (Montgomery-Asberg Depression Rating Scale) higher than 20, what matches medium severity of clinical state in CGI (ClinicalGlobal Impression ) scale higher or equal with 4.
4. Mental ability understand and sign informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Increased vulnerability to the development of psychosis ascertained on the basis a) M.I.N.I., b) family anamnesis of psychosis at relatives I. and II. degree.
2. Presence of another psychiatric disorder on axis I base on DSM- IV less than 6 months before inclusion to the study.
3. Contraindication for ketamine administration (hypertension, heart defect, severe cardiovascular disease, cerebrovascular accident in anamnesis, intracranial hypertension, glaucoma, hyperthyreosis, convulsions in anamnesis).
4. Using of drugs with strong anticholinergic efect.
5. Pregnant women, breastfeeding women or women without appropriate contraception.
6. Electroconvulsive treatment in the last 2 months before visit 1.
7. Treatment augmentation by lamotrigine, lithium, clozapine or IMAO (inhibitor of monoaminooxidase) in the last 2 weeks before visit 1.
8. Pharmaceuticals, illness and states, which may have influence on EEG (benzodiazepines, classical antipsychotics, head injury, encephalitis, epilepsy, etc.).
9. Clinically assessed serious suicidal risk.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified